Clomiphene Citrate Resistant Polycystic Ovary SyndromePhase 2NCT03674385

Efficacy of Vit E in PCOS Resistant to Clomiphene Citrate

A Phase 2 study testing vitamin E, Metformin and Clomiphene Citrate in people with Clomiphene Citrate Resistant Polycystic Ovary Syndrome, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study evaluate the addition of Vit E to clomiphene citrate in the treatment of poly cystic ovary.Half the patients will receive both Vit E and clomiphene citrate the other half will receive clomiphene citrate only. Read more about this study

Who is it for?: Ages 18 to 39 years, women only
Conditions the study is for: Clomiphene Citrate Resistant Polycystic Ovary Syndrome
What is being tested?: vitamin E, Metformin and Clomiphene Citrate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteEgypt
Study dates: 19 Jul 2018to 30 Mar 2019
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 39 years
Women only
No healthy volunteers
Adult

Who may be able to join

Patients will be diagnosed as having PCOS according to the Rotterdam criteria for diagnosis of PCOS
Age between 18 and 39 years.
Period of infertility >1 years.
No treatment taken during the last 2 months.
Patients who have previously received clomiphene citrate (CC) and being diagnosed as having CC resistance

Who cannot join

History of pelvic surgery or infertility factor other than anovulation
Endocrine disorders in the form of hypothyroidism or hyperthyroidism, hyperprolactinemia, and Cushing syndrome, as detected by history, examination, or investigations.
Known cases of endometriosis (approved histologically), uterine anomaly or hydrosalpinx, retinitis pigmentosa and vitamin K deficiency.
Consumption of vitamin and antioxidant supplementations in the last three-months before the trial start date.
Male factor infertility (sperm count < 5 million per milliliter, normal morphology <4%).
Elevated serum prolactin, T.S.H and F.S.H.
Patients diagnosed with diabetes mellitus

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Medical Center of Infertility
Banī Suwayf, 62521

Other trials in Egypt

About this study

Official title: Evaluation of the Clinical Outcome of Vitamin E as Adjuvant Therapy in Patients With Clomiphene Citrate Resistant Polycystic Ovary Syndrome

Read the detailed description

Clomiphene and vit E each used in treatment of pco but they do so by different mechanisms.

Clomifene is in the selective estrogen receptor modulator (SERM) family of medication. It works by causing the release of gonadotropin-releasing hormone by the hypothalamus, and subsequently gonadotropin from the anterior pituitary.

Vit E is used in treatment of pco due its anti-oxidant effect.

Conditions: Clomiphene Citrate Resistant Polycystic Ovary Syndrome
Being tested: vitamin E, Metformin, Clomiphene Citrate
Keywords: Vitamin E, Polycystic ovary
Medical subject headings: Polycystic Ovary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

vitamin EDietary supplement
Also called toco 1000
Vitamin E is sold as a dietary supplement, either by itself or incorporated into a multivitamin product. it also has anti-oxidant effect
MetforminDrug
Also called cidophage
Metformin is in the biguanide class. It works by decreasing glucose production by the liver and increasing the insulin sensitivity of body tissues. It is also used in the treatment of polycystic ovary syndrome (PCOS)
Clomiphene CitrateDrug
Also called clomid
is a medication used to treat infertility in women who do not ovulate

Study groups in NCT03674385
Study group	Role	What they receive
vitamin E group	Experimental	30 patient Receives: Dietary Supplement: vitamin E; Drug: Metformin; Drug: Clomiphene Citrate
control group	Active comparator	clomiphene Receives: Drug: Metformin; Drug: Clomiphene Citrate

What is being measured

The primary outcome is the main question the study is designed to answer.

ovulation rate
Follicles measure more than 18 mm will be considered mature follicles.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jul 201830 Mar 2019

First posted17 Sep 2018
Study start19 Jul 2018
Primary completion25 Mar 2019
Study completion30 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Clomiphene Citrate Resistant Polycystic Ovary SyndromeStudies of the same condition, open and under way.
More trials run by Ain Shams UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: prospective randomized controlled open label study
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03674385
Sponsor's protocol ID: PHCL 191
Status last verified: Jul 2020
First submitted: 15 Aug 2018
Last updated: 10 Jul 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Clinical Outcome of Vitamin E as Adjuvant Therapy in Patients With Clomiphene Citrate Resistant Polycystic Ovary Syndrome
ClinicalTrials.gov ID: NCT03674385
Acronym / sponsor ID: PHCL 191
Conditions: Clomiphene Citrate Resistant Polycystic Ovary Syndrome
Keywords: Vitamin E, Polycystic ovary
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Ain Shams UniversityUniversity, hospital or other
Collaborators: Misr University for Science and Technology
Study start: 19 Jul 2018 (actual)
Primary completion: 25 Mar 2019 (actual)
Study completion: 30 Mar 2019 (actual)
First posted: 17 Sep 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Clomiphene and vit E each used in treatment of pco but they do so by different mechanisms.

Vit E is used in treatment of pco due its anti-oxidant effect.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: prospective randomized controlled open label study

Arm	Type	Receives
vitamin E group	Experimental	Dietary Supplement: vitamin E, Drug: Metformin, Drug: Clomiphene Citrate30 patient
control group	Active comparator	Drug: Metformin, Drug: Clomiphene Citrateclomiphene

Who may qualify

Ages: 18 to 39 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Patients will be diagnosed as having PCOS according to the Rotterdam criteria for diagnosis of PCOS
Age between 18 and 39 years.
Period of infertility >1 years.
No treatment taken during the last 2 months.
Patients who have previously received clomiphene citrate (CC) and being diagnosed as having CC resistance

Key exclusion criteria (7 listed)

History of pelvic surgery or infertility factor other than anovulation
Endocrine disorders in the form of hypothyroidism or hyperthyroidism, hyperprolactinemia, and Cushing syndrome, as detected by history, examination, or investigations.
Known cases of endometriosis (approved histologically), uterine anomaly or hydrosalpinx, retinitis pigmentosa and vitamin K deficiency.
Consumption of vitamin and antioxidant supplementations in the last three-months before the trial start date.
Male factor infertility (sperm count < 5 million per milliliter, normal morphology <4%).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
vitamin EAlso: toco 1000Vitamin E is sold as a dietary supplement, either by itself or incorporated into a multivitamin product. it also has anti-oxidant effect	Dietary supplement	vitamin E group
MetforminAlso: cidophageMetformin is in the biguanide class. It works by decreasing glucose production by the liver and increasing the insulin sensitivity of body tissues. It is also used in the treatment of polycystic ovary syndrome (PCOS)	Drug	control group, vitamin E group
Clomiphene CitrateAlso: clomidis a medication used to treat infertility in women who do not ovulate	Drug	control group, vitamin E group

Primary outcome

ovulation rate
Time frame: 3 months
Follicles measure more than 18 mm will be considered mature follicles.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing vitamin E, Metformin and Clomiphene Citrate in people with Clomiphene Citrate Resistant Polycystic Ovary Syndrome, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ovulation rate (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03674385.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2020.